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Relevance of RBCs' phosphatidylserine and thromboinflammation in the genesis and prediction of thromboembolic events in emergency patients - the “RBC-Embodict” study.

Relevance of RBCs' phosphatidylserine and thromboinflammation in the genesis and prediction of thromboembolic events in emergency patients - the “RBC-Embodict” study. - RBC-Embodict

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035334
Enrollment
515
Registered
2024-10-25
Start date
2024-10-28
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I80.2

Interventions

Group 1: Study group of adult patients (= 18 years, n=500) presenting to the Central Emergency Department at Campus Benjamin Franklin - Charité, Universitätsmedizin Berlin, who have a clinical disposi
parameters of thrombin formation, thrombogenicity, inflammation (Prothrombin Fragment F1.2., Thrombin-Antithrombin Complex (TATcomplex), D-Dimer, Plasmin-alpha2-Antiplasmin Complex (PAPcomplex), Tissu

Sponsors

Charité, Universitätmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria Study group: - Patients aged =18 years who have been informed verbally and in writing about participation in the study and have signed the informed consent form. - Patients presenting via the Central Emergency Department at Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin - Patients who, according to the latest AWMF-S3 guideline: Prophylaxis of venous thromboembolism (VTE), have a low, medium or high clinical dispositional and/or exposure risk for VTE (see eCRF, AWMF-S3 guideline: Prophylaxis of venous thromboembolism (VTE)). Inclusion criteria Control group: - Patients aged =18 years who have been informed verbally and in writing about participation in the study and have signed the informed consent form. - Patients presenting via the Central Emergency Department at Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin - Patients who, according to the current AWMF-S3 guideline: Prophylaxis of venous thromboembolism (VTE), have no clinical risk of VTE (see eCRF, AWMF-S3 guideline: Prophylaxis of venous thromboembolism (VTE)).

Exclusion criteria

Exclusion criteria: - Refusal to participate in the study or declaration of unwillingness to participate in the study. - Patients not able to give consent. - Participation in this study in the past. - Underage patients. - Transfusion within the last 3 months. - Erythropoietin therapy within the last 3 months. - Patients who are currently enrolled in another study that involves blood sampling with more than 35 ml of blood per week.

Design outcomes

Primary

MeasureTime frame
- Comparison of the proportion of PS-positive erythrocytes in patients with and without clinical risk of VTE. - Correlation of the proportion of PS positive red cells with parameters of thrombin information, thrombogenicity and inflammation.

Secondary

MeasureTime frame
Predictive value (positive and negative predictive value) of PS expression on erythrocyte membranes in relation to: - Identification of VTE. - Clinical VTE scores (Wells Score TVT/LE, Geneva Score (revised) for PE, Caprini Score, Padua Prediction Score for Risk of VTE, Geneva Risk Score for VTE Prophylaxis, Ottawa Score, PERC-Rule, YEARS Algorithm for PE, Khorana Score). - VTE-associated or therapy-associated complications (bleeding, arrhythmias, infections, ischemia, stroke, death). - Initiation of anticoagulation. - “All-cause” mortality. - Need for inpatient therapy. - Duration of inpatient therapy. - Need for intensive care therapy.

Countries

Germany

Contacts

Public ContactFabian Depré

Charité, Universitätsmedizin Berlin

fabian.depre@charite.de(030) 450 552 402

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026